Garcia-Duran Carmen, Grau Francisco, Villacampa Guillermo, Oaknin Ana
Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Oncology Data Science (ODysSey) VHIO, Barcelona, Spain.
Int J Gynecol Cancer. 2022 Sep 6;32(9):1196-1200. doi: 10.1136/ijgc-2022-003370.
Currently, women diagnosed with high-risk locally advanced cervical cancer are at high risk of recurrence after treatment with concurrent chemoradiation and represent a population with high unmet need.
The primary objective is to evaluate the progression-free survival of high-risk locally advanced cervical cancer patients who have achieved a partial or complete response after chemoradiation after receiving dostarlimab as maintenance therapy.
The study aims to demonstrate that the use of dostarlimab, as maintenance therapy, would significantly increase progression-free survival in these patients.
ATOMICC trial is a phase II, randomized, open-label, multicenter study to assess the efficacy and safety of anti-PD1, dostarlimab, as maintenance therapy in patients with high-risk locally advanced cervical cancer who have achieved a partial or complete response after chemoradiation. The control arm entails a clinical and radiological follow-up, with no further treatment (current standard of care). ATOMICC trial is an investigator-driven trial sponsored by GEICO (Grupo Español de Investigación en Cáncer de Ovario) and supported by GlaxoSmithKline (GSK).
MAJOR INCLUSION/EXCLUSION CRITERIA: Women aged over 18 years with a biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix meeting the following staging criteria: International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IB2, IIA2, IIB with pelvic lymph node involvement, FIGO stages IIIA, IIIB, IVA, and any FIGO 2009 stage with para-aortic lymph node involvement are eligible for the trial. All patients must have achieved a partial or complete response after definitive concurrent chemoradiation. Women diagnosed with FIGO stage IVB, having undergone a previous hysterectomy, or having a history of active autoimmune disease will not be considered eligible.
Progression-free survival defined as the time from the date of randomization to the date of first disease progression or death due to any cause, whichever occurs first.
A total of 132 patients are expected to be recruited in the study, using a 1:2 (control:experimental arm) randomization allocation ratio.
The trial was launched in Q2-2019 and the trial is estimated to be closed for recruitment in Q3-2022. Results are expected to be released in Q3-2024.
The trial is registered at ClinicalTrials.gov (NCT03833479).
目前，被诊断为高危局部晚期宫颈癌的女性在同步放化疗后复发风险很高，是需求未得到充分满足的人群。
主要目标是评估接受度伐利尤单抗作为维持治疗的高危局部晚期宫颈癌患者在放化疗后达到部分或完全缓解后的无进展生存期。
该研究旨在证明使用度伐利尤单抗作为维持治疗可显著提高这些患者的无进展生存期。
ATOMICC试验是一项II期、随机、开放标签、多中心研究，旨在评估抗PD-1药物度伐利尤单抗作为维持治疗对高危局部晚期宫颈癌患者的疗效和安全性，这些患者在放化疗后已达到部分或完全缓解。对照组进行临床和影像学随访，不再进行进一步治疗（当前的标准治疗）。ATOMICC试验是一项由西班牙卵巢癌研究小组（GEICO）发起、葛兰素史克（GSK）支持的研究者发起的试验。
主要纳入/排除标准：年龄超过18岁、经活检确诊为宫颈鳞状细胞癌、腺癌或腺鳞癌且符合以下分期标准的女性：国际妇产科联盟（FIGO）2009分期为IB2、IIA2、伴有盆腔淋巴结受累的IIB期，FIGO IIIA、IIIB、IVA期，以及任何伴有主动脉旁淋巴结受累的FIGO 2009分期均符合试验条件。所有患者在确定性同步放化疗后必须达到部分或完全缓解。被诊断为FIGO IVB期、既往接受过子宫切除术或有活动性自身免疫性疾病史的女性将不被视为符合条件。
无进展生存期定义为从随机分组日期到首次疾病进展或因任何原因死亡的日期，以先发生者为准。
预计该研究共招募132名患者，采用1:2（对照组：试验组）的随机分配比例。
该试验于2019年第二季度启动，预计2022年第三季度结束招募。预计结果将于2024年第三季度公布。
该试验已在ClinicalTrials.gov（NCT03833479）注册。
